Lung Disease,ObstructiveNCT02592122
Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease
A study testing Salbutamol Aerosol and No drugs in people with Lung Disease,Obstructive, run by snow at 1 site in China.
Trial summary
In the patients with COPD mechanical ventilation, the bronchial dilatation is very common. However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Disease,Obstructive
- What is being tested?
- Salbutamol Aerosol and No drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute exacerbation of chronic obstructive pulmonary disease
- The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours
Who cannot join
- asthma
- has received tracheotomy
- long term mechanical ventilation (which has been accepted for more than 21 days).
- severe pneumonia
- Patients who cannot use a patient with bronchial dilation
- there's a taboo on the use of a sedative.
- refusal to participate in the study
- 48 hours to pull out the tube
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of respiratory and critical care medicine,Beijing Chao-yang Hospital
Beijing, Beijing Municipality, 100020
Xue Wang, MB, 0086-10-85231543, rtxue2013@sina.com
Bing Sun, MD, 86013911151075, ricusunbing@126.com
About this study
In the patients with COPD mechanical ventilation, the bronchial dilatation is very common. However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. For patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study can be used to guide the clinical medication through the test of the bronchus. If the patients with bronchial dilation test positive were used in the test, the patients were not used. In this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.
- Conditions
- Lung Disease,Obstructive
- Being tested
- Salbutamol Aerosol, No drugs
- Keywords
- Mechanical ventilation, Chronic obstructive pulmonary disease, Airway resistance, Bronchial dilation test
- Medical subject headings
- Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol AerosolDrug
Also called Ammonium bromide bromide aerosol
No drugsDrug
| Study group | Role | What they receive |
|---|---|---|
| Atomization inhalation | Active comparator | First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Second, randomly selected into the atomization group Receives: Drug: Salbutamol Aerosol |
| Without atomization inhalation | Active comparator | First of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Secondly, the random selection is not the atomization group Receives: Drug: No drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
airway resistance
The first test of bronchial dilatation
Measured: 1 day
Respiratory mechanics index:PEEPi
Measured: 1 day
Secondary outcomes (4)
Mechanical ventilation time
Measured: 28 days
length of hospital stay
Measured: 30 days
Costs of hospitalization expenses
Measured: 30 days
Routine blood test:Eosinophilic cells
Measured: 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2013
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Disease,ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- snow
- Sponsor type
- University, hospital or other
- Collaborators
- Primary-investigator,Bing Sun
- Responsible party
- Sponsor-investigator, snow, Beijing Chao Yang Hospital
- Investigators
- Bing Sun, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592122
- Sponsor's protocol ID
- 2013-10-COPD
- Status last verified
- Oct 2015
- First submitted
- 11 Oct 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Y, Chen Y, Wang P. Application of impulse oscillometry and bronchial dilation test for analysis in patients with asthma and chronic obstructive pulmonary disease. Int J Clin Exp Med. 2015 Jan 15;8(1):1271-5. eCollection 2015.
PubMed 25785124
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Responsiveness in Patients With AECOPD Mechanical Ventilation by Inspiratory and Bronchial Dilation Testchronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02592122
- Acronym / sponsor ID
- 2013-10-COPD
- Conditions
- Lung Disease,Obstructive
- Keywords
- Mechanical ventilation, Chronic obstructive pulmonary disease, Airway resistance, Bronchial dilation test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- snowUniversity, hospital or other
- Collaborators
- Primary-investigator,Bing Sun
- Study start
- Oct 2013
- Primary completion
- Oct 2016 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the patients with COPD mechanical ventilation, the bronchial dilatation is very common. However, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. For patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses. Therefore, this study proposes an objective evaluation method to evaluate the response of COPD patients to bronchial dilation. The hypothesis of this study can be used to guide the clinical medication through the test of the bronchus. If the patients with bronchial dilation test positive were used in the test, the patients were not used. In this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomization inhalation | Active comparator | Drug: Salbutamol AerosolFirst of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Second, randomly selected into the atomization group |
| Without atomization inhalation | Active comparator | Drug: No drugsFirst of all, investigators need to give patients to do the test, the result is more than 12% is positive group, less than 12% is negative group.Secondly, the random selection is not the atomization group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Acute exacerbation of chronic obstructive pulmonary disease
- The mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours
Key exclusion criteria (8 listed)
- asthma
- has received tracheotomy
- long term mechanical ventilation (which has been accepted for more than 21 days).
- severe pneumonia
- Patients who cannot use a patient with bronchial dilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salbutamol AerosolAlso: Ammonium bromide bromide aerosol | Drug | Atomization inhalation |
| No drugs | Drug | Without atomization inhalation |
Primary outcome
airway resistance
Time frame: 1 day
The first test of bronchial dilatation
Respiratory mechanics index:PEEPi
Time frame: 1 day
4 secondary outcomes
Mechanical ventilation time
Time frame: 28 days
length of hospital stay
Time frame: 30 days
Costs of hospitalization expenses
Time frame: 30 days
Routine blood test:Eosinophilic cells
Time frame: 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2015.
- Background: PubMed 25785124Li Y, Chen Y, Wang P. Application of impulse oscillometry and bronchial dilation test for analysis in patients with asthma and chronic obstructive pulmonary disease. Int J Clin Exp Med. 2015 Jan 15;8(1):1271-5. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bing Sun principal investigator
Beijing Chao Yang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salbutamol Aerosol and No drugs in people with Lung Disease,Obstructive, run by snow at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xue Wang, MB (0086-10-85231543, rtxue2013@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
airway resistance (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2015.